2/13/2013

Frost & Sullivan Sees Urgent Need for Cancer Diagnostics Tests; Finds Unmet Need for Key Disorders

The range of potential therapeutic approaches available to treat cancer is expected to expand rapidly during the next decade. Current diagnostic technologies focus on detection and diagnosis of cancer using mainly blood, feces, urine tests, or genetic tests. Testing methods are now gradually moving toward targeted treatment with the help of companion diagnostics, which help track disease progress, enabling patients to be treated with appropriate drugs.

New analysis from Frost & Sullivan (http://www.healthcare.frost.com), Western European In Vitro Cancer Diagnostics Market, finds that the market earned revenues of $736 million in 2011 and estimates this to reach $1519.8 million in 2019. The research covers immunoassay, immunohistochemistry, nucleic acid testing (NAT), clinical chemistry, and other diagnostic methods. The growing prevalence of cancer, together with greater patient awareness, will drive test volumes. Despite falling prices, the massive increase in test volumes will keep the market on an upward trajectory.

“The projected launch of new NAT products for cancer diagnosis will result in high growth rates and revenue generation in this segment,” notes Frost & Sullivan Senior Research Analyst Divyaa Ravishankar. “NAT products have the ability to determine the predisposition of the disease condition. They address the need for diagnostic tests that aid in the early detection and prevention of cancer.”

This is in keeping with the current focus on characterizing cancer in an asymptomatic phase or in a predisposition phase. Substantial research is being undertaken in Western Europe to validate the use of biomarkers in cancer detection. Biomarkers and associated techniques are set to play an increasingly important role in the development of oncology therapeutics.

While these are positive signs, consolidation has increased the bargaining power of laboratories, allowing them to squeeze the prices of cancer-related tests. The demand is now for high-capacity, high-volume laboratory solutions, rather than high-value, labor-intensive tests like NAT.

“On the one hand, efforts will have to be made to facilitate the integration of novel NAT technologies with existing laboratory systems,” advises Divyaa Ravishankar. “On the other hand, the development of innovative and more accurate tests, paralleled by initiatives at improving patient awareness about these new options, could create a pull effect from patients, which could negate the increasing bargaining power of the centralised lab.”

If you are interested in more information on this study, please send an email with your contact details to Anna Zanchi, Corporate Communications, at anna.zanchi@frost.com.

Inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS) represent two families of bowel disorders with a common denominator of significant unmet medical need. The main unmet need in IBD is disease modifying therapies with greater efficacy in order to slow disease progression and maintain remission, particularly for severe patients. The development pipeline is bursting with potential candidates to treat IBD. In comparison, however, the IBS pipeline is relatively dry as drug developers struggle to unwind the complex pathology behind this disorder. The main unmet need in IBS is effective therapies indicated specifically to alleviate the symptoms of this syndrome.

New analysis from Frost & Sullivan’s (http://www.healthcare.frost.com) Analysis of the Expanding US Market for Gastrointestinal Disorders Prescription Pharmaceuticals research finds that prescription pharmaceuticals indicated for IBD and IBS earned revenues of approximately $4.26 billion in 2011 and estimates this to reach $7.70 billion in 2017. The analysis finds that the growth is aided by an expansion of the market for biologicals and the introduction of efficacious new therapies.

“Growth opportunities exist for biologicals and other novel agents, particularly for those that justify initiation of therapy earlier in the course of IBD, as well as for first line therapies that incorporate important improvements, such as enhanced delivery or administration,” noted Frost & Sullivan Life Sciences Senior Industry Analyst Debbie Toscano. “There is also a tremendous need for safe and effective treatments for severe forms of IBS, which affects a very sizeable patient population.”

Biological therapies, such as tumor necrosis factor (TNF) inhibitors prove very effective in getting and keeping IBD patients in remission. However, these drugs are typically reserved for more severe patients who have tried and failed standard first line therapies such as aminosalicylates and steroids.

“As evidence accumulates supporting first line use of biologics for improved outcomes for patients, tremendous growth opportunity exists if payers and clinicians are willing to adopt the new treatment paradigm,” remarked Ms. Toscano. “Considerable opportunity also exists to penetrate the largely untouched IBS market, an indication for which the US FDA recognizes significant unmet need.”

However, knowledge gaps in the underlying pathology of these diseases impede the identification of new drug targets and development of agents with superior efficacy compared to available therapies. Patient adherence to complicated therapeutic regimens can also hinder market uptake.

“The most important success factor for companies is the marketing of safe and effective therapies with a robust clinical history,” concluded Ms. Toscano. “This will raise awareness and gain the confidence of prescribing gastroenterologists, patients, and payers.”

If you are interested in more information on this research, please email Britni Myers, Corporate Communications, at britni.myers@frost.com, with your full name, company name, job title, telephone number, company email address, company website, city, state and country.

Lycera Expands Partnership With Merck; Potential $600-Million Deal

Lycera Corp. recently announced a collaboration agreement with Merck to discover, develop, and commercialize small-molecule therapies directed to selected novel targets being investigated for the treatment of a broad range of immune-mediated disorders.

This new relationship between the two companies builds on a previous agreement announced in 2011 focused on therapies targeting the retinoic acid related orphan receptor, the key transcription factor coordinating both differentiation of T-helper 17 (Th17) cells and production of highly pro-inflammatory mediators, such as interleukin-17 (IL-17).

“We are absolutely delighted to expand our relationship with Merck, a collaboration that builds on the culture of scientific excellence fostered by both companies,” said Kathleen M. Metters, PhD, Lycera’s President and CEO. “Lycera’s proven track record in accelerating early stage programs to development candidate status holds the potential to fuel Merck’s early stage pipeline.”

Under the terms of the agreement, Lycera will receive an up-front payment and research funding, and is eligible to receive in excess of $300 million in research, development, regulatory, and commercial milestone payments. Further details of the financial terms were not disclosed. Merck is responsible for clinical development and will have worldwide marketing and commercialization rights to any products that may be developed as a result of the collaboration. Lycera is entitled to receive royalty payments, as well as development and sales milestones, on global sales from any such products.

“There are substantial unmet medical needs and opportunities in autoimmune disorders, and new targets representing attractive opportunities that we are very pleased to pursue through our new collaboration with Lycera,” said Rupert Vessey, DPhil, FRCP, Senior Vice President, Global Scientific Strategy, Merck Research Laboratories. “Lycera’s innovative capabilities and productivity, exemplified by the retinoic acid related orphan receptor program on which we currently collaborate, make them ideal partners for Merck in this area of drug discovery.”

Lycera Corp. is focused on the discovery and development of selective, small molecule immune-modulators for the treatment of patients with autoimmune diseases, such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Lycera is developing drug candidates for novel therapeutic targets that have the potential for first-in-class oral efficacy without the adverse effects of current standard-of-care antiproliferative and immunosuppressive agents. For more information, visit www.lycera.com.

Perrigo Buys Company for $283 Million

Perrigo Company recently announced it has signed a definitive merger agreement and has completed the acquisition of Leeds, U.K.-based Rosemont Pharmaceuticals Ltd. for approximately $283 million in cash. Founded in 1967, Rosemont is a specialty and generic prescription pharmaceutical company focused on the manufacturing and marketing of oral liquid formulations. Rosemont’s current portfolio consists of more than 90 products and is well positioned for future growth given its diverse product pipeline, relevant favorable demographics, and export opportunities. Rosemont’s net sales during calendar year 2012 were approximately more than $60 million with gross and operating margins similar to those of Perrigo’s Rx pharmaceuticals segment, where Rosemont’s results of operations will be included. Key benefits of the transaction include:

Attractive Specialty Market: Rosemont’s portfolio of liquid formulations addresses a critical medicinal need within pediatrics, as well as for those patients with dysphagia (swallowing difficulties), a common malady in a growing elderly population.

Immediate Access to Oral Liquid Formulations: The transaction is aligned with Perrigo’s strategic growth objective to expand into additional liquid categories and diversified prescription medicines to further broaden its customer product portfolio.

Leadership Position in Sizeable and Growing Market: Favorable demographic drivers have been increasing demand for easier to swallow products. Rosemont’s leading position in this market today, combined with its robust pipeline portfolio and access to under-penetrated international markets, represents an exciting opportunity for future growth and European expansion.

Synergy Opportunity: The acquisition allows Perrigo to expand its UK portfolio while leveraging its established distribution and administrative infrastructures and long-standing customer relationships.

“We continue to focus on expanding our international footprint and view the acquisition of Rosemont as an opportunistic next step given our existing presence in the UK,” said Perrigo Chairman, President, and CEO Joseph C. Papa. “Similar to Perrigo’s position in the niche US extended topical generic prescription market, Rosemont is the No. 1 player in the niche specialty UK oral liquid formulations market. We are excited to announce the acquisition of Rosemont and welcome its more than 200 employees to the Perrigo family. This transaction represents another step forward executing our strategy to make quality healthcare products more affordable for consumers around the world.”

Rosemont is expected to be $0.08 accretive to adjusted EPS for the remainder of fiscal 2013, and approximately $0.04 to $0.07 dilutive to GAAP EPS after the inclusion of estimates for intangible amortization, transaction, and integration related expenses.

Including this acquisition, Perrigo now expects fiscal 2013 reported earnings to be between $4.67 and $4.87 per diluted share as compared to $4.18 in fiscal 2012 and fiscal 2013 adjusted earnings to be between $5.53 and $5.73 per diluted share as compared to $4.99 in fiscal 2012.

From its beginnings as a packager of generic home remedies in 1887, Allegan, Michigan-based Perrigo Company has grown to become a leading global provider of quality, affordable healthcare products. Perrigo develops, manufactures, and distributes OTC and generic Rx pharmaceuticals, infant formulas, nutritional products, pet health, dietary supplements, APIs. For more information, visit www.perrigo.com.

Novozymes Biopharma Announces Agreement With EpiVax

Novozymes Biopharma recently announced a collaborative research agreement with Rhode Island-based biotech company, EpiVax, Inc. to help further the development of a potential paradigm-shifting treatment for autoimmune diseases. The research agreement will involve linking EpiVax’s proprietary Tregitope (T regulatory epitopes) immune-modulating therapy for the treatment of type 1 diabetes, to Novozymes’ proven Albufuse half-life extension platform, helping to enhance its pharmacokinetic and pharmacodynamic properties. As a result, it will be possible to modulate half-life of the therapy to offer improved control, enhancing the overall efficacy of treatment.

“Novozymes is delighted to announce a research agreement with EpiVax in the key area of autoimmune diseases treatment,” said Dave Mead, Business Development Director at Novozymes Biopharma. “The two technologies jointly have a role to play in a wide-range of treatments for autoimmune diseases. By taking EpiVax’s pioneering therapy and combining it with Novozymes’ versatile and clinically demonstrated Albufuse technology, along with the unparalleled expertise of our R&D scientists, we will work together to move the treatment to the next stage in its development.”

EpiVax has identified a set of natural Tregitopes derived from Immunoglobulin G (IgG) that induce tolerance to immunogenic proteins. Preliminary studies in the area of type 1 diabetes have indicated that Tregitopes specifically induce natural Tregs and, when co-administered with an antigen, lead to the expansion of antigen-specific regulatory T cells. Modulation of auto-immune responses to autologous epitopes by induction of antigen-specific tolerance may prevent ongoing beta-cell destruction and restore the production of insulin. Combining EpiVax’s therapy with Novozymes’ robust and proven Albufuse technology will create a safe and effective platform for application of tregitopes to multiple autoimmunity, transplantation, and allergy conditions.

“Novozymes’ proven solutions, technical expertise, and reputation as a reliable partner makes it the ideal company for us to work with as we move our Tregitope immune-modulating technology closer to clinical trials. By bringing together our unique knowledge and experience in our respective fields, we look to develop an industry-changing technology that will make significant advancements in treating patients with autoimmune diseases,” said Dr. Annie De Groot, CEO/CSO at EpiVax, Inc.

Novozymes’ albumin-based technology offers significant benefits for delivery of a wide-range of molecules as it has the potential to tailor half-life according to specific medical requirements. Albumin’s proven safety, regulatory profile, and long history of therapeutic use, makes it an ideal choice for drug delivery. The broadly applicable platform has an established regulatory pathway enabling products to reach the market more efficiently and cost effectively. In addition, the technology can be used to reduce dose rates and side effects, while improving patient quality of life. These innovations pave the way for flexibility and efficiency for manufacturers developing novel therapies. For more information on Novozymes’ products and technologies, visit www.biopharma.novozymes.com.

EpiVax, Inc. is a Providence, RI biotechnology company focused on the development of vaccines and immunotherapeutics. EpiVax is one of the world’s leading innovators in the field of Immunogenicity Screening. The company uses immunoinformatics tools to screen protein therapeutics and to deimmunize these drugs so as to reduce adverse effects in the clinic. The Tregitope technology adds to the EpiVax Immunogenicity Toolbox, as it is expected to improve tolerance of protein drugs such as replacement enzymes, blood factors, and monoclonal antibodies. For more information, visit www.epivax.com.

Second Expansion Underway for Rexam Healthcare

Four years after its first extension, Rexam is again expanding its La Verpillière site (near Lyon) to create a building including approx. 2400 m2 of clean room exclusively dedicated for the production of sub-sets of insulin injection pens for the Eli Lilly and Company group.

Since 2008, Rexam Healthcare has been the European supplier for the Eli Lilly and Company group of the sub-sets of their insulin injection pen. This production is carried out by Rexam Healthcare at its La Verpillière plant in Isère (France).

This site specialises in drug administration systems, such as inhalers for asthma and injection devices, which enable the patient to self-administer their medicines. It also houses Rexam Healthcare’s European Technology Centre.

Four years ago, this collaboration between Rexam and Lilly led to the first extension of the site and created around 50 new jobs at La Verpillière with plans to double in size by the end of 2013. The project represents a significant investment over a 3-year period.

Composed of over a dozen plastic parts and a metal spring, this new insulin injection pen for the treatment of diabetes has two sub-sets: the dose selection mechanism, and the protective cap. The glass cartridge filled with insulin, which is inserted in the pen, is produced by the Eli Lilly and Company group at their Fegersheim site near Strasbourg. This is also where the two sub-sets are assembled and the insulin cartridge inserted.

The components of the injection pen will be manufactured by a fleet of dedicated robots, including injection presses, marking machines, assembly line with ultrasound welding, and packaging technology. Each phase will be controlled by a camera system. Designed to be produced by multi-imprint moulds on electric injection presses, the plastic parts will be in a material chosen specifically by the Eli Lilly and Company group.

More than 3,000 m2 of the building are already reserved exclusively for the manufacture of this product. 2,400 m2 out of the additional extension of 3,700 m2 will be clean rooms complying with standard ISO8.

Rexam Healthcare provides solutions to protect and deliver pharmaceuticals. Building on its core expertise in plastic injection, injection blow-molding, and high-speed automated assembly, the company designs, develops, and manufactures innovative packaging, including containers and closures, drug delivery devices, metering pumps and valves, and medical components to improve patients’ health. For more information, visit www.rexam.com/healthcare.

Xenon Receives Major Milestone for Marketing Approval

Xenon recently announced it has received a milestone payment from uniQure BV for the European Commission marketing approval of Glybera, a novel gene therapy treatment for the orphan disease lipoprotein lipase deficiency (LPLD), and the first gene therapy approved in the Western world.

Xenon exclusively licensed to uniQure BV its rights to the LPL^S447X genetic variant that causes a gain of function in the lipoprotein lipase (LPL) gene in humans. Humans with the LPL^S447X variant have been shown on average to have lower triglyceride and higher HDL cholesterol levels than those without LPL^S447X. Glybera developed by uniQure is an adeno-associated virus based human gene therapy that contains LPL^S447X and in clinical studies, Glybera was effective in reducing blood fat levels and episodes of pancreatitis in patients with LPLD.

“The approval of Glybera is an important milestone for our company and for the gene therapy field in general,” said Simon Pimstone, President and CEO of Xenon. “Xenon was founded with a commitment to advancing human genetic discoveries into novel therapies for difficult to treat orphan diseases, and Glybera is the first product to be marketed by one of our licensees.”

In addition to the milestone payment, Xenon is also entitled to receive from uniQure BV royalty payments on sales of Glybera, which is expected to start selling in Europe in 2013. The LPL^S447X technology in Glybera was conceived and developed by Xenon’s former CSO Michael Hayden at the Center of Molecular Medicine, University of British Columbia. Xenon is a privately owned, clinical genetics-based drug discovery and development company engaged in developing novel therapies for rare diseases. For more information, visit www.xenon-pharma.com.